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K Number
K982408
Device Name
AEROTEE, MODEL # 1001
Manufacturer
PIPER MEDICAL PRODUCTS
Date Cleared
1998-09-14

(66 days)

Product Code
CAF
Regulation Number
868.5630
Type
Traditional
Panel
AN
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

For use with pneumatic small volume nebulizers to deliver aerosolized medication.

Device Description

Not Found

AI/ML Overview

I am sorry, but based on the provided text, there is no information available regarding the acceptance criteria or any study that proves the device meets specific acceptance criteria. The document is a 510(k) clearance letter from the FDA for the AeroTee device, which confirms its substantial equivalence to legally marketed predicate devices. It does not contain details about performance studies, statistical analyses, or the metrics you've requested.

§ 868.5630 Nebulizer.

(a)
Identification. A nebulizer is a device intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing. Heated, ultrasonic, gas, venturi, and refillable nebulizers are included in this generic type of device.(b)
Classification. Class II (performance standards).